Safety and Tolerability of Tenofovir, Lamivudine, and Dolutegravir Regimen in South Indian Adult Human Immunodeficiency Virus-1 Patients

Abstract

Background: The fixed-dose combination of tenofovir, lamivudine, and dolutegravir (TLD) is the World Health Organization’s recommended first-line regimen for human immunodeficiency virus (HIV) treatment due to its potent virologic suppression and high tolerability. However, concerns remain regarding its long-term safety, especially in diverse populations. Objective: The objective of this study was to assess the safety, tolerability, and adverse effects of the TLD regimen among HIV-positive individuals in a real-world South Indian patient. Methods: An ambispective study was conducted on 1021 HIV-1-positive patients aged 19–75 years receiving the TLD regimen at a district ART center. Adverse drug reactions (ADRs), laboratory parameters, opportunistic infections (OIs), and treatment tolerability were analyzed. Data were collected from medical records and patient reports. Statistical analysis included Chi-square tests and binary logistic regression. Results: Among the participants, 659 ADRs
were reported, with nausea (18.06%), headache (16.23%), and rash (14.87%) being the most common. Older age (40–59 and 60–75 years) and male gender were associated with increased ADR risk. Hepatitis B co-infection
showed a near-significant association with higher ADR (odds ratio = 2.788, P = 0.057). OIs were reported in 15.7%, predominantly pulmonary tuberculosis (9.6%). Tolerability was high, with 87.3% of patients rating
their experience as “Excellent.” Laboratory abnormalities included anemia (59.3%) and dysglycemia (24.0%), with minimal hepatic or renal toxicity. Conclusion: The TLD regimen demonstrates excellent tolerability and
efficacy with a manageable safety profile. Monitoring for anemia, metabolic changes, and age-related ADR risks is recommended to optimize treatment outcomes in HIV care programs.